National Center for Emerging and Zoonotic Infectious Diseases

Mpox Vaccine Work Group: Introductio

ACIP MeetingOctober 25, 2023Pablo Sanchez MDThe Ohio State University−Na0onwide Children’s HoChair, ACIP Mpox Work Group
Global mpox outbreak, 2022

 First case in this outbreak identified in the United Kingdom in  Primarily affecting gay, bisexual, and other men who have se

(MSM)

 Associated with person-to-person spread via close skin-to-sk

including sex

 Deaths have occurred, primarily among persons with severe 

immunocompromise from advanced HIV

 U.S. case counts and deaths comprising 1/3 of cases and dea

– >30,800 cases– 54 deaths
Current global cases reported to WHO, Septe

2023

https://worldhealthorg.shinyapps.io/mpx_global/
JYNNEOS

 Comprised of replication-deficient vaccinia virus Administered subcutaneously* via 2 vaccine doses, 28 days ap Effectiveness assessed by comparing immunologic response t

ACAM2000

 Licensed for prevention of both smallpox and mpox Is recommended for persons with HIV and other immunocom

conditions

 Licensed for persons ≥ 18 years of age; an NIH trial is underwa

safety and immunogenicity for persons 12-17 years of age

*During the 2022 mpox outbreak, it was also administered intradermally because of limited vaccine availab

in enough supply
Outbreak recommendation: February and Ju

meetings Vote: ACIP recommends the 2-dose* JYNNEOS vaccine ser

persons aged 18 years and older at risk of mpox during an outbreak† 

*Dose 2 administered one month after dose 1†Public health authorities determine whether there is an mpox outbreak; a single case m

mpox outbreak at the discretion of public health authorities. Other circumstances in whresponse may be indicated including ongoing risk of introduction of mpox into a commuactivity in another geographic area

 Outbreak recommendations intended for any U.S. mpox o

regardless of whether associated with male-to-male sexua

 Clinical guidance, including about use of vaccine in childre

outbreaks discussed
National mpox vaccination strategy for pre-exposure 

vaccination during current outbreak*

*https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html

Vaccination before exposure to mpox virus

-Gay, bisexual, and other MSM, transgender or nonbinary people (includwho fall into the aforementioned categories) who in the past 6 months h• New diagnosis of ≥ 1 sexually transmitted disease• More than one sex partner-People with the following in the last 6 months:• Sex at commercial sex venue• Sex in association with large public event in geographic area where m

is occurring

-Sexual partners of people with the above risks-People who anticipate experiencing above risks-People with HIV or other causes of immunosuppression who have had 

anticipate potential mpox exposure
Elimination of human-to-human transmission

 WHO strategy in development; additional resources and data  Immunization may be one component of the strategy Elimination is a complex issue not addressed by WG; howeve

recommendation that persons at-risk for mpox during the onoutbreak receive the vaccines if they have not already, may supcoming WHO strategy
Recommendation that will be proposed duri

meetingACIP recommends vaccination* with the 2-dose

† JYNNEOS vaccin

persons aged 18 years and older at risk for mpox

§?

*Interim recommendation to be revisited in 2-3 year

s

† Dose 2 administered 28 days after dose 1§ Persons at risk: • Gay, bisexual, and other men who have sex with men, transgender or nonbinary p

in the past 6 months have had one of the following:

• A new diagnosis of ≥ 1 sexually transmitted disease• More than one sex partner • Sex at a commercial sex venue• Sex in association with a large public event in a geographic area where mpox 

transmission is occurring

• Sexual partners of persons with the risks described in above

• Persons who anticipate experiencing any of the abov

e
Potential implications of interim routine 

recommendation Increase vaccine coverage and prevent or minimize outbreak Remove some stigma and facilitate 1:1 consultation with clin

appointments
Potential commercialization of JYNNEOS

 Product sponsor (Bavarian Nordic) has indicated they will att

commercialize the vaccine if it is on a routine schedule

 This will transition vaccine from U.S. government stockpiles (

intended for smallpox preparedness) to the commercial secto
Tentative timeline for ACIP discussions and v

Interim routinerecommendation and clinical guidance 

October 2023 Early 2024 Possibly 2024

Publication of 2 MMWRs:1) Use of JYNNEOS during mpox

outbreaks

2) Use of JYNNEOS among 

persons at risk during the ongoing mpox outbreak

Consider results from NIH trial about use of JYNNEOS in persons aged 12-18 years

*February 2023 and June 2023 votes do not impact existing recommendations for the current mpox outbreak. § https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html
Proposed recommendation

ACIP recommends vaccination* with the 2-dose

† JYNNEOS vaccin

persons aged 18 years and older at risk for mpox

§?

*Interim recommendation to be revisited in 2-3 year

s

† Dose 2 administered 28 days after dose 1§Persons at risk: • Gay, bisexual, and other men who have sex with men, transgender or nonbinary pe

in the past 6 months have had one of the following:

• A new diagnosis of ≥ 1 sexually transmitted disease

• More than one sex partner • Sex at a commercial sex venue• Sex in association with a large public event in a geographic area where mpox 

transmission is occurring

• Sexual partners of persons with the risks described in above

• Persons who anticipate experiencing any of the abov

e
Goal for today’s meeting

 Updates from the ongoing outbreak

– Epidemiology: Dr. Faisal Minhaj– Evidence to recommendations framework: Dr. – Clinical guidance and next steps: Dr. Agam Rao

 Vote

– Mpox vote– Mpox Vaccines for Children vote
WG members

ACIP MemberPablo SánchezBeth Bell Ex Officio and Liaison MembersCSTE: Chris Hahn / Paul Cieslak

ASTHO: Ericka McGowan

NACHO: Philip HuangFDA: Sixun Yang, Clement 

Meseda & Alonzo García

ACOG: Howard MinkoffAAP: Jim Campbell

HRSA: Vikram Krishnasamy

AIM: Rob Schechter / Jane APHL: Jafar Razeq

NIH: Janet Lathey / KimberIHS: Matthew ClarkNACI: Nicole Forbes / JoshIDSA: Shireesha Dhaniredd

Invited ConsultantsSubject matter experts: IngIsaacs, Mike Merchlinsky & 

Zarrabian (HHS/BARDA)

Clinician experts in STIs, HImaternal vaccination, vaccequity, smallpox vaccinatiooccupational health
Clinician experts

STIs, HIV, and mpox(adult and peds):

Jason Zucker

Pablo TebasVince MarconiKim WorkowskiBonnie Maldonado

Immunizations (including for special populations) and vaccine safety:Ruth KarronFlor Munoz-RivasKathy Edwards

Health equity, vaccination including for smallpox:

Joel Breman

Gerard Vong

Occupational Medicine anMark Russi
CDC contributors

Mpox epi, lab, and vaccine experts

Andrea McCollum

Christy HutsonSathesh Panayampalli

Infection control, worker safety:Marie de Perio David KuharVaccine safety

Jonathan Duffy

Michael McNeil

Regulatory AffairsYon YuSTIs and HIVLaura BachmannLeandro Mena

John Brooks Alexa Oster

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For more information, contact CDC

1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.govThe findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Thank you!